Events

Device Recall Regard 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Resource Optimization & Innovation Llc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    72052
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0187-2016
  • 사례 시작날짜
    2015-08-25
  • 사례 출판 날짜
    2015-10-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139792
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Warmer, irrigation solution - Product Code LHC
  • 원인
    Custom surgical kits contain a component (ors fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
  • 조치
    On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.

Device

Device Recall Regard

Manufacturer

Resource Optimization & Innovation Llc
  • 제조사 주소
    Resource Optimization & Innovation Llc, 2909 N Neergard Ave, Springfield MO 65803
  • Source
    USFDA